Boston Scientific Corporation recalls Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV27…

Recall date

November 19, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0917-2015

FDA classification

Class I

Brand / firm

Boston Scientific Corporation

Sold / distributed

Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.

Why it was recalled

Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.